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OpenTrials
Completed

NCT Number: NCT01837615

Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis

Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular. Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and the Photopill capsule was developed for this purpose.

An open-label, interventional, clinical trial was designed for assessment of the safety and feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative Proctitis.

Primary endpoints being: safety reflected by the number and severity of adverse events and mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition.

Furthermore clinical and biochemical parameters are monitored during the study.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Proctitis Rectal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Ulcerative Proctitis (Mayo grade 1/2)

Exclusion criteria

  • Symptomatic hemorrhoids
  • Pregnant or lactating females
  • Patients that have used any experimental treatment within 8 weeks prior to Day 0
  • Patient that have used any biologics therapies or immunomodulation agents and/or steroids 4 weeks prior to Day 0
  • Rectal therapy 2 weeks prior to Day 0

Treatment and study plan

Photopill treatment

Device

Other names: Photopill

Primary outcomes

  1. Adverse events

    Time frame: day 0-42

    Any adverse events reported by subjects

Secondary outcomes

  1. Inflammatory markers

    Time frame: day 0,14,28,42

    serum CRP, serum Hb/Ht, fecal Calprotectin

  2. Clinical Questionnaires

    Time frame: day 0,14,28,42

    Simple Clinical Colitis Activity Index Partial Mayo score

  3. Mucosal appearance at sigmoidoscopy

    Time frame: week 0,14,28.42

    endoscopic disease activity Mayo score and possible damage by device

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Photopill Medical Ltd

Registry information

Official study title

Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis

Acronym: Photopill

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 23, 2013
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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